FDA 483 - Biomat USA Inc - January 12, 2026

Between January 5 and January 12, 2026, the Food and Drug Administration (FDA) conducted an inspection of Biomat USA Inc, a source plasma collection center located in Mansfield, Ohio. The inspection resulted in the issuance of a Form 483, which details a significant violation regarding the facility"s failure to maintain accurate, real-time records for the processing of blood components. Specifically, an FDA investigator discovered that the facility was not recording significant processing steps at the time they were performed. On January 9, 2026, five plasma bottles were found in a storage rack even though their labels falsely indicated they had already been placed in the freezer. These units had exceeded the facility"s required time window for freezer placement, yet the documentation incorrectly showed they were processed within the permitted timeframe. While these bottles were eventually separated from the standard inventory, they had not been properly relabeled to reflect their status at the time of the inspection. This failure to document actions as they occur undermines the ability to trace the history of blood products accurately. Under the regulatory framework of the Food, Drug, and Cosmetic Act, Biomat USA Inc is expected to respond to these observations. The company should submit a written plan to the FDA describing the corrective actions they will implement to ensure documentation accuracy and operational compliance.